Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan

Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00705445

Enrollment

2745

Registered

2008-06-26

Start date

2008-11-30

Completion date

2012-07-31

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Growth, Malnutrition, Pneumonia

Keywords

Malnutrition, Diarrhea, Pneumonia, Growth, Zinc Supplements, Microbiome

Brief summary

Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.

Detailed description

WHO has recommended the use of zinc for the treatment of acute diarrhea. Literature supports up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea and respiratory infections, and its subsequent co-morbid conditions. As the potential mechanisms of action of zinc still remains to be established, this trial is proposed to evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity patterns and response to various enteric pathogens in a representative birth cohort randomly allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control population.

Interventions

DIETARY_SUPPLEMENTMicronutrient Supplementation without Zinc

This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid

DIETARY_SUPPLEMENTMicronutrient Supplementation with Zinc

This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.

OTHERNutritional Counselling and Education

This will contain Nutritional Counselling and Education.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 6 Months

Healthy volunteers

Yes

Inclusion criteria

* Children of ages 2 weeks to 6 months for recruitment into the Trial. Children of ages 6 months and onwards would eligible to receive intervention (in the form of Micronutrient Sprinkles)

Exclusion criteria

* Children with obvious congenital anomalies.

Design outcomes

Primary

Measure	Time frame
Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.	2 years

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026